Fentanyl, a pain relieving patch that is 100 times stronger than morphine and is used to treat patients with severe chronic pain when other types of treatment have failed, has been recalled.
Eighteen lots of Fentanyl Transdermal System 25mgs/hour C II patches, manufacturered by Corium International for the drug company Actavis, had to be recalled because it was timed released and the release of the drug was happening faster than normal.
Accelerated release can lead to excessive sedation, respiratory difficulties, slow breathing and pauses in breathing.
Although the product has not caused any injuries yet, the company have recalled it as a precaution to prevent any patients having breathing difficulties.
The affected lot was lot number 30349.
They have also recalled other lot numbers in case they too have a faulty timed release mechanism. The other lot numbers are:
30041, Exp 12/2011 30258, Exp 03/2012
30049, Exp 12/2011 30349, Exp 03/2012
30066, Exp 12/2011 30350, Exp 03/2012
30096, Exp 01/2012 30391, Exp 03/2012
30097, Exp 02/2012 30392, Exp 04/2012
30123, Exp 01/2012 30429, Exp 04/2012
30241, Exp 02/2012 30430, Exp 04/2012
30256, Exp 02/2012 30431, Exp 04/2012
30257, Exp 03/2012 30517, Exp 04/2012
Wholesalers and retailers are being asked to return any stocks of Fentanyl that they have, although consumers are not required to return it. The manufacturers and distributors say this is because it doesn’t pose a threat. However, since the Food and Drug Administration say that it has the potential to cause breathing difficulties, there clearly is some risk.
If you currently use this medication and you have any questions or you would like to report an adverse reaction, please phone the Actavis customer line on 1-877-422-7452.
You can also report an adverse reaction to the FDA by using their online service:
www.fda.gov/medwatch/report.htm